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FDA Grants Fast Track Designation for Iseganan
Designation as a fast track drug indicates that the FDA will facilitate the development and expedite the review of a new drug that is intended to treat a serious or life-threatening condition and that demonstrates the potential to address an unmet medical need. In a letter to the company, the FDA stated: "We are granting fast track designation for the following reasons:
1. There are currently no products approved (topical or systemic) for the prevention of ventilator-associated pneumonia.
2. Ventilator-associated pneumonia is commonly recognized as a highly morbid condition in critically ill patients. Prevention of this disorder is desirable."
Pneumonia is the most common infection among ventilated patients in the intensive care unit. The longer a patient is ventilated, the higher the risk of developing VAP. Approximately 15-30% of patients receiving mechanical ventilation for more than 48 hours get VAP. The company estimates that over 1 million patients annually are mechanically ventilated for more than 48 hours in North America, Western Europe and Japan combined, making VAP a significant unmet medical need. Once VAP occurs, antibiotics are administered systemically to treat the infection. In spite of the use of potent, broad-spectrum, antibiotics, patients who develop VAP generally remain dependent on artificial ventilation and remain in the intensive care unit for longer periods of time than patients who do not develop VAP. As a consequence, studies have demonstrated that patients who develop VAP can incur more than $40,000 in additional hospital charges. "VAP is a devastating complication experienced by critically ill patients who are vulnerable to infection because of the requirement for artificial ventilation," said Dr. Marin Kollef, Associate Professor of Medicine at Washington University School of Medicine, Pulmonary and Critical Care Division in St. Louis. "Experts have long believed that pneumonia in patients should be preventable through the use of antibiotic decontamination of the mouth, but so far we have lacked the appropriate antibiotic -- one that can be safely applied into the mouth and not worsen problems of antibiotic resistance. This approach has become more important as bacterial resistance to antibiotics continues to grow and the development of new antibiotics to cope with resistance has lagged. Because of iseganan's properties, VAP represents a logical and important potential application. We look forward to the results of coming pivotal clinical trials."
IntraBiotics has previously completed and announced results of a Phase I/II study of the safety and microbiologic efficacy of single and multiple doses of iseganan administered orally/topically to mechanically ventilated patients. In that study, IntraBiotics was able to determine the optimal dosage, formulation and frequency of administration of iseganan. Based on the results of that trial, and in collaboration with experts in the field of critical care medicine, infectious diseases and biostatistics, IntraBiotics has designed a pivotal efficacy and safety trial, the first of two trials planned to support registration of iseganan for the prevention of VAP. IntraBiotics is in discussions with the FDA to finalize the protocol for this upcoming trial. "We are pleased to be working with the FDA on incorporating their feedback into the protocol for the upcoming study because of the FDA's expertise in trial design and review. We believe that patients with VAP will benefit from FDA input by virtue of assuring that the collected data support expeditious product registration if the trials are successful," said Dr. Henry Fuchs, President and CEO of IntraBiotics.
Source: IntraBiotics Pharmaceuticals, Inc.